phase 2/3 study of kpl-387 in recurrent pericarditis

Conditions: Pericarditis; Pericarditis Acute; Recurrent Pericarditis

Summary: this study is being done to demonstrate whether kpl-387 is an effective and safe treatment for recurrent pericarditis.

this clinical trial is comprised of 3 separate study parts: phase 2, phase 3, and long-term extension. the primary objective of phase 2 is to evaluate how well different dose regimens of kpl-387 control the pain and inflammation of pericarditis in a group of participants experiencing an acute episode of recurrent pericarditis. this part of the study will confirm the kpl-387 dose regimen to be further tested in phase 3 and the long-term extension. the primary objective of phase 3 is to confirm the efficacy of kpl-387 for the treatment of recurrent pericarditis and reduction in risk of recurrence in an additional group of participants experiencing an acute episode of recurrent pericarditis. participants who complete phase 2 or phase 3 may be eligible to participate in the long-term extension. the primary objective of the long-term extension is to assess the long-term efficacy of kpl-387 while maintaining long-term disease control. all of the study parts also have other objectives to learn about the safety, tolerability, concentration of kpl-387 in blood, and effects of kpl-387 on blood test markers of immune activity in recurrent pericarditis.

Eligibility criteria:
key inclusion criteria: * phase 2 and 3: has a diagnosis of recurrent pericarditis * phase 2 and 3: has signs and symptoms of recurrent pericarditis despite treatment with standard therapies * phase 2 and 3: weighs at least 40 kg * phase 2: taking nsaids and/or colchicine (in any combination) * phase 3: taking nsaids and/or colchicine and/or glucocorticoids (in any combination) key exclusion criteria: * phase 2 and 3: has a diagnosis of pericarditis that is secondary to specific prohibited etiologies. * phase 2 and 3: has received an investigational drug during the 4 weeks before screening or is planning to receive an investigational drug at any time during the study. * phase 2 and 3: has a history of active or untreated, latent tuberculosis (tb) prior to screening. * phase 2 and 3: has a history of immunodeficiency. * phase 2 and 3: has a history of immunosuppression, including positive human immunodeficiency virus (hiv) test results. * phase 2 and 3: has chest x-ray at screening or within 12 weeks before first study drug administration, with evidence of malignancy, abnormality consistent with prior or active tb infection or active infection. * phase 2 and 3: has a history of malignancy of any organ system within the past 5 years before screening (other than a successfully treated non metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or localized carcinoma in situ of the cervix). * phase 2 and 3: has a known or suspected current active infection or a history of chronic or recurrent infectious disease (\> 3 episodes in prior 12 months), including but not limited to, genitourinary infection, chest infection, sinusitis, or skin/soft tissue infection. * phase 2 and 3: has had a serious infection, has been admitted to the hospital for an infection, or has been treated for a documented infection requiring antibiotics for a documented infection within 2 weeks prior to first study drug administration. * phase 2 and 3: has had an organ transplant (except corneal transplant performed more than 3 months prior to first study drug administration). * phase 2 and 3: in the investigator's opinion, has any other medical condition that could adversely affect the subject's participation or interfere with study evaluations.

Keywords: recurrence recurrent recurrent pericarditis kpl-387